PDH

Blanket, Neonatal Phototherapy

Product code

PDH

Device name

Blanket, Neonatal Phototherapy

Device class

Class 2

21 CFR

21 CFR 880.5700

Medical specialty

General Hospital

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification definition

Is intended to be used as an adjunct to neonatal phototherapy systems used for the treatment of neonatal hyperbilirubinemia in the clinical or home setting.

Definition text from the FDA device classification database (U.S. federal government work, public domain).